1 day ago Be among the first 25 applicantsGet AI-powered advice on this job and more exclusive features.Employee Log in Candidate Log in to Connect Homepage vitrolifegroup.ComDanish Portuguese (Brazil) Spanish SwedishFinanceValencia | HybridRegulatory Affairs SpecialistAbout The RoleAs Regulatory Affairs Specialist, you will lead regulatory initiatives across product development, manufacturing, and distribution. You’ll liaise with regulatory authorities, support global sales growth through new product registrations and ongoing regulatory maintenance. You’ll thrive in a collaborative environment alongside highly skilled and dedicated colleagues. This role focuses on ensuring our products and genetic services meet global regulatory requirements throughout the product lifecycle – from development through commercialization – in close collaboration with our post‑market surveillance team.Key ResponsibilitiesCompliance Monitoring: Ensure ongoing compliance with regulations across Europe, the Middle East and Africa (e.G., EU IVDR 2017/746, LDT frameworks, DHA regulations).Regulatory Submissions: Prepare and compile regulatory dossiers for new and existing IVD products and lab‑developed tests.Cross‑functional Collaboration: Work closely with R&D;, Quality Assurance, Clinical Affairs, and Marketing to support regulatory strategies and product development.Regulatory Intelligence: Monitor changes in global regulatory landscapes and assess their impact on company products and processes.Documentation Management: Maintain regulatory files and records in accordance with internal procedures and regulatory requirements.Who are you?Hold a Bachelor’s or Master’s degree in biology, chemistry, physics, or equivalent or experience in regulatory affairs for ART.Bring 2–5 years of experience in regulatory affairs, preferably within the IVD or medical device industry.Possess strong knowledge of EU IVDR and/or ISO 15189 requirements.Systematic and analytical, yet proactive and pragmatic in finding solutions within a dynamic environment.Detail‑oriented, decisive, and a true team player, who builds strong relationships.Curious and passionate about regulatory affairs with a technical interest in genetic services.Fluent in both Spanish and English.Preferred SkillsRAC (Regulatory Affairs Certification) is a plus.Experience with software‑based IVDs or IEC 62304 is highly desirable.Why Join UsBe part of a mission‑driven team improving patient outcomes through innovative diagnostics.Work in a collaborative, fast‑paced environment with opportunities for growth.Enjoy a competitive salary, benefits, and support for ongoing professional development.Apply todayWe’re eager to fill this position and will conduct interviews on a rolling basis until the right candidate is found. We look forward to hearing from you!Seniority levelMid‑Senior levelEmployment typeFull‑timeVitrolife Group is a integral provider of medical devices and genetic services. We develop products and services for personalized genetic information and medical device products, supporting clinical practice for fertility treatment. Our headquarters are in Gothenburg, Sweden, with about 1,100 colleagues worldwide.#J-18808-Ljbffr